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Product NDC Code | 83623-161 | ||||
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Drug Name | Joint-ritis pain relieving roll-on |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | OINTMENT | ||||
RxCUI drug identifier | 581794 | ||||
Application Number | M017 | ||||
Labeler Name | Lifeline Naturals of America, Inc. | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Menthol 16% w/v
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Directions • adults and children 12 years of age and older: Apply a small amount gently into affected area not more than three to four times daily • shake well before use • children under 12 years of age: Do not use, consult a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Chondroitin Sulfate, Copaiba Balsam ( Copaifera officinalis ) Resin Oil, D-Glucosamine Sulfate, Eucalyptus Oil, Lanolin, Lavender Oil, Olive-Pomace Oil
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses temporarily relieves minor aches and pains of muscles and joints due to arthritis • simple backache • sprains • strains • bruises
Purpose
Information about the drug product’s indications for use.Purpose Pain reliever
Spl product data elements
Usually a list of ingredients in a drug product.JOINT-RITIS PAIN RELIEVING ROLL-ON Menthol MENTHOL, UNSPECIFIED FORM MENTHOL CHONDROITIN SULFATE (BOVINE) COPAIBA OIL GLUCOSAMINE SULFATE EUCALYPTUS OIL LANOLIN LAVENDER OIL OLIVE OIL
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Packaging rollon
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
ORIGINAL FORMULA MAXIMUM STRENGTH 100% NATURAL ALCOHOL-FREE ROLL-ON Distributed by: Lifeline Naturals of America 325 SW 15th Ave., Pompano Beach, FL 33069 (954)532--5390 [email protected] www.realjointritis.com PAIN RELIEF THAT’S EASY ON YOUR SKIN Introducing JOINT-RITIS®, the ultimate solution for relieving minor joint pain. This remarkable topical pain reliever goes deep beneath the surface to provide you with penetrating pain relief. Unlike other topical analgesics that dry the skin, JOINT-RITIS® contains skin conditioners Lanolin, Glucosamine, & Chondroitin to keep the skin hydrated. And now, we've taken it to the next level with maximum strength Menthol for pain-relief Lot # & Expiry located on the bottom of the container All Natural Menthol Joint Pain Relief Ointment Also For Muscle Aches & Strains, Neck & Lower Back Pain
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? +1-954-532-5390 You may also report serious side effects to phone number. Mon - Thu: 8:30 AM - 5:30 PM
Storage and handling
Information about safe storage and handling of the drug product.Other information • because product is all-natural, consistency may change with temperature variations • if thickening occurs, run bottle under warm water or warm in palms of hands • store at room temperature, protected from light and heat
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warnings For external use only When using this product • avoid contact with the eyes or mucous membranes; if product gets into eyes, rinse thoroughly with water • do not apply to wounds or damaged skin • do not bandage tightly • do not use with electric heating pads Stop use and ask a doctor if • condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days • a rash or irritation develops If pregnant or breast-feeding , ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API